The Effect of Stress Ball on Labor Pain, Anxiety and Satisfaction in Labor

Phd Student Msc Midwifery Öznur HAYAT ÖKTEM

The aim of this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery.

H1 Using the Stress Ball in Labor reduces labor pain. H2 Using the Stress Ball in Labor Reduces Anxiety H3 Use of Stress Ball in Labor increases labor satisfaction.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Labor
• Intervention / Treatment: Behavioral: stress ball group

Detailed Description

Birth is accepted as one of the physiological behaviors that have existed since the beginning of mankind and whose formation cycle has not changed. Birth is a health condition that many women desire at some point in their lives. While birth is a normal physiological process and should be an important tool for happiness, it also carries risks such as pain, suffering and discomfort. For this reason, one of the first thoughts a pregnant woman has about childbirth is labor pain. Birth pain is a central and universal part of a woman birth experience.Causes of labor pain include psychological factors such as fear and anxiety, previous experiences, birth environment, lack of information and inadequate support, as well as physical causes such as uterine contractions, cervical dilatation and effacement. Anxiety and tension experienced by pregnant women during the labor process can slow down the progress of labor. Anxiety also reduces women self-confidence, and pregnant women perceive themselves as inadequate and incompetent. Anxiety experienced during labor leads women to cesarean section at their own request.

Utilizing non-pharmacologic and supportive methods to reduce labor pain is an important part of nursing/midwifery practices. Providing alternatives that allow women to make active decision-making to reduce pain management and anxiety during labor may affect pain, anxiety and hormonal oscillations. Currently, alternative strategies to reduce the use of medication during labor are being considered.

In line with the results of this study, it is thought that the stress ball may be effective in labor, where anxiety and pain are frequently experienced.

After obtaining all official permissions, it is planned to collect the data face-to-face. In the data collection phase, the researcher will first explain the purpose of the study to the women who meet the inclusion criteria and inform them about the study through written consent of the women will be obtained. When the women in the control and experimental groups are admitted to the delivery room, the Introductory Information ; will be collected by the researcher by face-to-face interview method. In addition,;State Anxiety Scale; will be administered during the first admission, VAS before cervical dilatation 0-3 cm, 3-8 cm and 8-10 cm and before placenta emergence, and ;State Anxiety Scale; will be administered when dilatation is 0-3 and 3-8 cm (at the beginning and end of the active phase of labor).;Birth Satisfaction Scale; will be administered in the first 24 hours after delivery before the patient is discharged. Data collection will be done similarly in both groups.

According to randomization, pregnant women in the intervention group will receive ;stress ball therapy; during labor.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem UĞURLU, associate professor; Phone Number: 05555807841; Email: meltemugurlu17@gmail.com

Study Locations

• Turkey
  • Karabük, Turkey, 78100
    • Recruiting
    • Karabuk Training and Research Hospital, obstetrics clinic
    • Contact: PhD student Öznur HAYAT ÖKTEM, Phd Student Msc Midwife; Phone Number: +905053202563; Email: oznurhayat_78@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being at 38 weeks or more of pregnancy,
• Having a single, healthy fetus in head position,
• Applying during the latent phase of labor (cervical dilatation between 0-3 cm), .To give birth vaginally.

Exclusion Criteria:

• Having become pregnant through assisted reproductive techniques,
• Having a gestational or chronic disease,
• Having an obstacle to giving birth vaginally,
• Suspicion of fetal anomaly,
• Not volunteering to work,
• Women under the age of 18,
• Women who are illiterate in Turkish,
• Decision to perform caesarean section during labor,
• The participant wishes to withdraw from the research,
• Development of fetal distress,
• Using vacuum or forceps during birth, .Women with vision, hearing or mental problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine care
Experimental: Experiment; Stress ball group	Behavioral: stress ball group; According to randomization, pregnant women in the intervention group will receive "stress ball therapy" during labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor pain	The pregnant woman's pain will be evaluated with VAS.	Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.
Anxiety	The state anxiety scale will be filled for anxiety .	State anxiety scale will be administered in the latent phase before the stress ball is applied and at 8 cm after the stress ball is applied.
Birth satisfaction status	A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.	This form will be administered in the first 24 hours after delivery before discharge.

Collaborators and Investigators

• Sponsor: Öznur Hayat Öktem

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: satisfaction; anxiety; labor pain; Stress ball
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: Hayatoktem03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No